Table 1.

Summary of covariates per participant.

Study	IDa	CAB PKb ≤Q1	RPV PKb ≤Q1	HIV-1 subtype A6/A1	Baseline IN L74Ic	Baseline INSTI mutationd	Baseline Proviral RPV RAMe	Baseline NNRTI RAMf	Female sex at birthg	BMI ≥30 kg/m2	Q8W
ATLAS-2M	1	✓			✓	✓	✓	✓	✓	✓	✓
ATLAS-2M	2	✓	✓	✓	✓				✓	✓	✓
ATLAS	3	✓	✓	✓	✓		✓		✓
ATLAS	4	✓	✓				✓	✓	✓	✓
FLAIR	5	✓	✓	✓	✓			✓		✓
FLAIR	6	✓	✓	✓	✓				✓	✓
FLAIR	7	✓	✓	✓	✓				✓	✓
ATLAS-2M	8			✓	✓		✓	✓	✓	✓	✓
ATLAS-2M	9	✓	✓
ATLAS	10		✓	✓	✓
ATLAS-2M	11						✓	✓		✓	✓
ATLAS-2M	12		✓								✓
ATLAS-2M	13							✓

CAB, cabotegravir; CVF, confirmed virologic failure; IN, integrase; INSTI, integrase strand transfer inhibitor; NNRTI, nonnucleoside reverse transcriptase inhibitor; PK, pharmacokinetics; Q1, first quartile; Q8W, every 8 weeks; RAM, resistance-associated mutation; RPV, rilpivirine.

^aParticipants were from study sites in Russia (n = 6), France (n = 2), US (n = 2), Spain (n = 1), South Africa (n = 1), Canada (n = 1). Follow-up at Russian study sites did not find clustering of failures at any one particular site, reducing the likelihood of drug administration errors being the cause.

^bCAB and RPV PK refer to Week 8 trough concentrations (4 weeks following first injections); Q1 refers to the lowest quartile of the Week 8 trough concentration.

^cExcluding mixtures with L74M.

^dExcluding L74I (excluding mixtures with L74M).

^eReduced RPV susceptibility was observed with 11/13 participants at CVF. Baseline genotype and phenotype were analysed using viral RNA from plasma samples in FLAIR and viral DNA from peripheral blood mononuclear cell samples in ATLAS and ATLAS-2M.

^fExcluding RPV RAMs.

^gThere were six out of 1039 (<1%) participants included in the analysis whose self-reported gender differed from sex at birth – none of these six participants reported CVF.